FDA.reportPublic FDA data

AMLODIPINE BESYLATE

Product NDC
82009-026
11-digit product format
820090026
Labeler code
82009
Product ID
82009-026_72ad7e01-b3db-46b3-af3f-746e5ec70cd0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AMLODIPINE BESYLATE
Dosage form
TABLET
Route
ORAL
Labeler
Quallent Pharmaceuticals Health LLC
Application
ANDA077073
Marketing category
ANDA
Marketing start
2022-12-01
Substance
AMLODIPINE BESYLATE
Active strength
2.5 mg/1
Pharmacologic classes
Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
AMLODIPINE BESYLATE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMLODIPINE BESYLATE2.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii864V2Q084H
Rxcui197361, 308135, 308136

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fa898d56-9495-d6f0-309b-68a5d8e3914aProduct name420260305
c19ec24d-2c40-4b8d-7c20-500ffa3660a1Product name320260303
b15e9aa6-d523-ca97-480e-570e0543a342Product name420251024
265792b3-b999-c010-7364-a7db20b9d4d9Product name520250515
14c2c15b-f823-4ada-a40e-a440544294dcProduct name120221207
a72887ef-d675-499f-af4b-78688f6855cdProduct name120191002
a4484670-2869-6416-f6ff-03b1b3cbd1b0Product name220190415
4a27501f-a987-48a5-99b4-e983d4744d76Product name720181211
18600d07-613d-bf9c-2711-fe40c06f3393Product name520180703
bded1554-44de-900a-5297-403365d6d4b2Product name320170110
1f1c6e4b-bbad-4649-afd1-7a1d671db4b1Product name120150316
63ab5fbf-2a6b-c41d-051a-39e845d718b1Product name120140508
7613b1a5-acb6-4e5e-6048-c44deeeb1212Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82009-026-10AMLODIPINE BESYLATE1000 in 1 BOTTLETABLET10004
82009-026-90AMLODIPINE BESYLATE90 in 1 BOTTLETABLET904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82009-026-10EA - Each82009-026f0bf3610-f2a3-4562-b469-43ce3c9d915512024-04-05
82009-026-90EA - Each82009-026657dd8bb-91ee-487c-a2de-5d49d64034c112023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82009-026AMLODIPINE BESYLATE TABLET [QUALLENT PHARMACEUTICALS HEALTH LLC]3Current NDC, Legacy NDC, 2 package rows20250403_c262dedb-1d13-4447-9355-f11e1dbbfb4d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308135amLODIPine besylate 10 MG Oral TabletPSNc262dedb-1d13-4447-9355-f11e1dbbfb4d4
308136amLODIPine besylate 2.5 MG Oral TabletPSNc262dedb-1d13-4447-9355-f11e1dbbfb4d4
197361amLODIPine besylate 5 MG Oral TabletPSNc262dedb-1d13-4447-9355-f11e1dbbfb4d4
308135amlodipine 10 MG Oral TabletSCDc262dedb-1d13-4447-9355-f11e1dbbfb4d4
308136amlodipine 2.5 MG Oral TabletSCDc262dedb-1d13-4447-9355-f11e1dbbfb4d4
197361amlodipine 5 MG Oral TabletSCDc262dedb-1d13-4447-9355-f11e1dbbfb4d4
308135amlodipine (as amlodipine besylate) 10 MG Oral TabletSYc262dedb-1d13-4447-9355-f11e1dbbfb4d4
308136amlodipine (as amlodipine besylate) 2.5 MG Oral TabletSYc262dedb-1d13-4447-9355-f11e1dbbfb4d4
197361amlodipine (as amlodipine besylate) 5 MG Oral TabletSYc262dedb-1d13-4447-9355-f11e1dbbfb4d4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
82009-026-10820090026101000 TABLET in 1 BOTTLE (82009-026-10) 1000 tablet2023-12-15NoNoCurrent
82009-026-908200900269090 TABLET in 1 BOTTLE (82009-026-90) 90 tablet2022-12-010000-00-00NoNoCurrent